KR20230043193A - TWO-PIECE RAPIDLY INSERTABLE CENTRAL CATHETERS, INTRODUCERS THEREFOR, AND METHODS THEREOF - Google Patents

Abstract

A two-piece rapid insertable central catheter ("RICC"), introducer, and method are disclosed. For example, the distal catheter piece of the RICC and the introducer may be combined in an introducer assembly configured to be operated with one finger of the same hand while the introducer is held between the thumb and the other finger or fingers of the hand. The introducer's catheter-advancing hub includes a manifold coupled to a proximal portion of the distal catheter-hub piece of the distal catheter piece. The introducer needle of the syringe of the introducer has a needle shaft extending through the manifold and the distal end of the distal catheter piece. The introducer housing is over the syringe tip, manifold and proximal portion of the distal catheter piece. The introducer housing of the introducer is configured to provide column strength to the catheter tube of the distal catheter piece during venipuncture.

Description

TWO-PIECE RAPIDLY INSERTABLE CENTRAL CATHETERS, INTRODUCERS THEREFOR, AND METHODS THEREOF

The present disclosure relates to a catheter, and more particularly to a rapidly insertable central catheter.

Existing catheters are made entirely of ready-to-use catheters. Such catheters may have a length in the range of 30-40 cm as measured from the proximal end of the catheter to the distal end. Rapidly Insertable Central Catheters (RICCs) currently under development can be introduced over an introducer needle. However, introducing RICC through a 30-40 cm introducer needle can be a cumbersome task for some clinicians. In addition, it can be difficult to timely determine whether blood flashback has occurred and access to the vessel lumen during a given RICC introduction procedure with a 30-40 cm introducer needle. Accordingly, RICCs generally include a distal introduction aperture designed to introduce the RICC over a shorter introducer needle. However, it would be advantageous to eliminate the introduction apertures as they become artifacts in nature after RICC introduction.

To solve the above problems, a two-piece RICC, an introducer therefor, and a method method thereof are disclosed herein.

Disclosed herein is a RICC system comprising an introducer configured to engage in an introducer assembly having a ready-to-deploy state in some embodiments and a distal catheter piece of the RICC. The introducer assembly is configured to be operated with one finger of the hand while the introducer is held between the thumb and the other finger or fingers of the hand. The distal catheter piece includes a distal catheter-hub piece of a two-piece catheter hub and a catheter tube coupled to the distal catheter-hub piece by a proximal portion of the catheter tube. The catheter tube includes one or more catheter-tube lumens. The introducer includes a catheter-advance hub, an introducer needle, a syringe, and an introducer housing. The catheter-advance hub includes a manifold and a side arm coupled to a proximal portion of the distal catheter-hub piece in a ready-to-deploy state of the introducer assembly. The introducer needle has a needle shaft that extends through both the manifold and the distal end of the distal catheter piece in a ready-to-deploy condition of the introducer assembly. The syringe includes a barrel having a distal portion terminating in a syringe tip. A syringe is fluidly coupled to the introducer needle. The introducer housing overlies the syringe tip, manifold, and proximal portion of the distal catheter piece in the ready to deploy introducer assembly. The introducer housing is configured to provide column strength to the catheter tube during venipuncture with the introducer needle. The introducer housing is also configured to be longitudinally split so that the distal catheter piece can be removed from the introducer housing after venipuncture.

In some embodiments, the introducer housing includes a locking portion at a distal portion of the introducer housing. The lock includes a hook on a slidable piece of the introducer housing and a latch on a stationary piece of the introducer housing. The hook and latch are configured to lock the slidable piece and stationary piece together in a ready-to-deploy state of the introducer assembly.

In some embodiments, the stationary piece of the introducer housing includes a channel. The channel includes a latch in a proximal portion of the channel and a ramp in a distal portion of the channel. The hook and ramp combination is configured to push the slidable piece of the introducer housing away from the anchoring piece when the distal face of the hook engages the proximal face of the ramp while advancing the slideable piece distally relative to the anchoring piece.

In some embodiments, the introducer housing includes a sliding hinge at a proximal portion of the introducer housing. The sliding hinge includes a captive tab of the slidable piece of the introducer housing and a track of the stationary piece of the introducer housing. The captive tab is captively but slidably positioned in the track so that the slideable piece can be advanced distally relative to the stationary piece without separating the slideable piece from the stationary piece of the proximal portion of the introducer housing. do.

In some embodiments, a proximal portion of the captive tab on the inside of the outer surface of the introducer housing is radial. The radially directed captive tab facilitates separating the slidable piece of the introducer housing from the stationary piece of the introducer housing at the distal portion of the introducer housing.

In some embodiments, the proximal portion of the introducer housing includes a longitudinal cutout. The cutout is configured to provide a pathway for a side arm of the catheter-advancing hub while advancing the catheter-advancing hub distally within the introducer housing.

In some embodiments, the manifold includes one or more manifold lumens equal in number to one or more catheter-tube lumens. The one or more manifold lumens are fluidly connected to the one or more catheter tube-lumens in a ready-to-deploy state of the introducer assembly.

In some embodiments, the side arm of the catheter-advancing hub includes a side-arm lumen fluidly coupled to one or more manifold lumens. The combination of the side-arm lumen and the one or more manifold lumens is for simultaneous priming of each of the one or more catheter-tube lumens prior to insertion of the catheter tube into a lumen of a patient's blood vessel. For example, a patient may include a human or non-human subject.

In some embodiments, the catheter-advance hub further includes a catheter-advance push tab extending from the side arm. The catheter-advancing push tab is configured to advance the catheter-advancing hub distally with one finger of the hand while holding the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand.

In some embodiments, the RICC system further includes a proximal catheter piece of the RICC. The proximal catheter piece includes a proximal catheter-hub piece of a two-piece catheter hub and one or more extension legs. The one or more extension legs each include one or more extension-leg lumens. Each extension leg of the one or more extension legs is coupled to the proximal catheter-hub piece by a distal portion of the extension leg. RICC has a connection where the proximal catheter-hub piece is connected to the distal catheter-hub piece. In the connected state of the RICC, one or more extension-leg lumens are each fluidly coupled to one or more catheter-tube lumens across the two-piece catheter hub.

In some embodiments, the RICC includes a set of three lumens in a concatenated state of the RICC. The set of three lumens includes a primary lumen, a secondary lumen, and a tertiary lumen.

In some embodiments, the primary lumen has a primary lumen opening at the distal end of the two-piece catheter, the secondary lumen has a secondary lumen opening on the side of the catheter tube proximal to the primary lumen opening, and a tertiary lumen opening has a tertiary lumen opening on the side of the catheter tube proximal to the secondary lumen opening.

In some embodiments, the catheter tube further comprises a first section formed of a first material having a first durometer, a second section formed of a second material having a second durometer smaller than the first durometer. Thus, the catheter tube is configured to have both the column strength for inserting the catheter tube into the patient and the compliance to advance the catheter tube through the patient's vasculature.

In some embodiments, the introducer further comprises a syringe housing around the barrel of the syringe, having a distal portion and a proximal portion. A proximal portion of the syringe housing is integral with or coupled to a proximal portion of a plunger disposed within the barrel. Whether the proximal portion of the syringe housing is integral with or coupled to the proximal portion of the plunger, sliding the syringe housing proximally relative to the barrel withdraws the plunger from the barrel.

In some embodiments, the syringe further includes a plunger-withdrawal push tab, which plunger-withdrawal push tab extends proximally up the barrel from a distal portion of the barrel to which the tab is coupled. The plunger-withdrawal push tab holds the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand while pushing with one finger of the hand to slide the syringe housing proximally against the barrel and withdraw the plunger from the barrel. is configured to

In some embodiments, the introducer further comprises an access guidewire disposed within an access-guidewire lumen formed by at least the plunger lumen of the plunger and the needle lumen of the introducer needle. The access guidewire is of sufficient length to extend the access guidewire through the distal end of the distal catheter piece.

In some embodiments, the introducer further includes a slider extending distally from the syringe housing and up the barrel. The slider is configured to actuate the access guidewire with one finger of the hand while holding the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand. The slider includes an extension extending through a longitudinal slot in each of the barrel and plunger and into an access guidewire lumen, where the extension is coupled to the access guidewire.

Also disclosed is an introducer configured to couple to a distal catheter piece of a RICC in an introducer assembly. The introducer includes a catheter-advance hub, an introducer needle, a syringe, and an introducer housing. The catheter-advancing hub includes a manifold and a side arm configured to couple to a distal catheter piece of an introducer assembly. The introducer needle has a needle shaft that extends through both the manifold and the distal end of the distal catheter piece in a ready-to-deploy condition of the introducer assembly. A syringe is fluidly coupled to the introducer needle. The syringe includes a barrel having a distal portion terminating in a syringe tip. The syringe is configured to be held around the distal portion of the barrel between the thumb and the other finger or fingers of the hand, leaving one finger to actuate the introducer. The introducer housing overlies the syringe tip, manifold, and proximal portion of the distal catheter piece in the ready to deploy introducer assembly. The introducer housing is configured to provide column strength to the catheter tube of the distal catheter piece during venipuncture with the introducer needle. The introducer housing is also configured to be longitudinally split so that the distal catheter piece can be removed from the introducer housing after venipuncture.

In some embodiments, the introducer housing includes a locking portion at a distal portion of the introducer housing. The lock includes a hook on the slideable piece of the introducer housing and a latch on the stationary piece of the introducer housing. The hook and latch are configured to lock the slideable piece and the stationary piece together.

In some embodiments, the stationary piece of the introducer housing includes a channel. The channel includes a latch in a proximal portion of the channel and a ramp in a distal portion of the channel. The hook and ramp combination is configured to push the slidable piece of the introducer housing away from the anchoring piece when the distal face of the hook engages the proximal face of the ramp while advancing the slideable piece distally relative to the anchoring piece.

In some embodiments, the introducer housing includes a sliding hinge at a proximal portion of the introducer housing. The sliding hinge includes a captive tab of the slidable piece of the introducer housing and a track of the stationary piece of the introducer housing. The captive tab is captively but slidably positioned in the track to allow the slideable piece to advance distally relative to the stationary piece without separating the slideable piece from the stationary piece of the proximal portion of the introducer housing. do.

In some embodiments, a proximal portion of the captive tab on the inside of the outer surface of the introducer housing is radial. The radially directed captive tab facilitates separating the slidable piece of the introducer housing from the stationary piece of the introducer housing at the distal portion of the introducer housing.

In some embodiments, the proximal portion of the introducer housing includes a longitudinal cutout. The cutout is configured to provide a pathway for a side arm of the catheter-advancing hub while advancing the catheter-advancing hub distally within the introducer housing.

In some embodiments, the side arm of the catheter-advancing hub includes a side-arm lumen fluidly coupled to one or more manifold lumens. The combination of the side-arm lumen and the one or more manifold lumens is for simultaneous priming of each lumen of the one or more lumens of the distal catheter piece of the RICC in readiness for deployment of the introducer assembly.

In some embodiments, the catheter-advance hub further includes a catheter-advance push tab extending from the side arm. The catheter-advancing push tab is configured to advance the catheter-advancing hub distally with one finger of the hand while holding the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand.

In some embodiments, the introducer further comprises a syringe housing around the barrel of the syringe, having a distal portion and a proximal portion. A proximal portion of the syringe housing is integral with or coupled to a proximal portion of a plunger disposed within the barrel. Whether the proximal portion of the syringe housing is integral with or coupled to the proximal portion of the plunger, sliding the syringe housing proximally relative to the barrel withdraws the plunger from the barrel.

In some embodiments, the syringe further includes a plunger-withdrawal push tab, which plunger-withdrawal push tab extends proximally up the barrel from a distal portion of the barrel to which the tab is coupled. The plunger-withdrawal push tab holds the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand while pushing with one finger of the hand to slide the syringe housing proximally against the barrel and withdraw the plunger from the barrel. is configured to

In some embodiments, the introducer further comprises an access guidewire disposed within an access-guidewire lumen formed by at least the plunger lumen of the plunger and the needle lumen of the introducer needle. The access guidewire is of sufficient length to extend the access guidewire through the distal end of the distal catheter piece in a ready-to-deploy condition of the introducer assembly.

In some embodiments, the introducer further includes a slider extending distally from the syringe housing and up the barrel. The slider is configured to actuate the access guidewire with one finger of the hand while holding the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand. The slider includes an extension extending through a longitudinal slot in each of the barrel and plunger and into an access guidewire lumen, where the extension is coupled to the access guidewire.

Also disclosed is a method of a RICC system. The method, in some embodiments, includes a RICC system-acquiring step, a needle track-establishing step, a first RICC-advancing step, an introducer housing-splitting step, and an introducer-removing step. The RICC system-acquisition phase includes RICC system acquisition. The RICC system includes a proximal catheter piece of the RICC and an introducer assembly. The introducer assembly includes an introducer and a distal catheter piece of a RICC disposed partially within the introducer housing of the introducer. The needle track-establishing step includes establishing a needle track from the skin region of the patient to the lumen of the blood vessel with an introducer needle of an introducer. The introducer needle has a needle shaft that extends through the distal end of the distal catheter piece in a ready-to-deploy condition of the introducer assembly. The needle track-establishment step is performed while maintaining the distal portion of the introducer's syringe between the thumb and the other finger or fingers of the hand, while at least one finger of the hand is ready to use to actuate the introducer assembly. The first RICC-advance step includes advancing the distal portion of the first section of the catheter tube of the distal catheter piece over the needle shaft and into the lumen of the vessel. The introducer housing-splitting step includes dividing the introducer housing along the length of the introducer housing. The introducer-removing step includes removing the distal catheter piece from the introducer housing leaving the distal portion of the first section of the catheter tube in place within the lumen of the vessel.

In some embodiments, the method further comprises blood aspiration. The blood aspiration step includes aspirating blood with a syringe to ensure that the needle tip of the introducer needle is placed within the lumen of the vessel prior to the introducer-removal step. The blood drawing step involves pushing the plunger-withdrawal push tab with one finger of the hand while holding the distal portion of the syringe by the syringe housing over the barrel of the syringe between the thumb and the other finger or fingers of the hand. The plunger-withdrawal push tab extends from the distal portion of the syringe to the barrel such that pushing the plunger-withdraw tab slides the syringe housing proximally relative to the barrel and withdraws the plunger connected to the syringe housing from the barrel while retaining the distal portion of the syringe by the syringe housing. extend upwards

In some embodiments, the first RICC-advancing step includes pushing the catheter-advancing push tab with one finger of the hand while holding the distal portion of the syringe between the thumb and the other finger or fingers of the hand. The catheter-advance push tab is part of a catheter-advance hub that is coupled to the proximal portion of the distal catheter piece in a ready-to-deploy state of the introducer assembly.

In some embodiments, pushing the catheter-advancing push tab advances the side arm of the catheter-advancing hub along a path provided by a longitudinal cut-out in the introducer housing.

In some embodiments, the method further comprises a priming step. The priming step includes priming the distal catheter piece with a common syringe through the side arm of the catheter-advance hub prior to the first RICC-advance step. The side arm has a side-arm lumen fluidly coupled to the one or more manifold lumens for simultaneously priming each lumen of each one or more lumens of the distal catheter piece.

In some embodiments, the introducer housing-splitting step includes unlocking a lock in a distal portion of the introducer housing by sliding a slidable piece of the introducer housing distally relative to a stationary piece of the introducer housing. Unlocking the lock includes disengaging the hook of the slidable piece and the latch of the stationary piece by sliding the slideable piece against the stationary piece.

In some embodiments, the stationary piece of the introducer housing includes a channel including a latch at a proximal portion of the channel and a ramp at a distal portion of the channel. Sliding of the slidable piece against the stationary piece causes the distal face of the hook to engage the proximal face of the ramp and divides the introducer housing along the length of the introducer housing.

In some embodiments, the method further comprises an access guidewire-advancing step. The access guidewire-advancing step includes advancing an access guidewire disposed within the access guidewire lumen over the distal end of the distal catheter piece and into the vessel lumen. The access-guidewire lumen is formed from at least the plunger lumen of the syringe and the needle lumen of the introducer needle. Further, advancing the slider distally with one finger while holding the distal portion of the syringe housing between the thumb and the other finger or fingers of the hand couples the slider to the access guidewire such that the access guidewire is advanced into the vessel lumen. The access guidewire-advance step is performed before the first RICC-advance step.

In some embodiments, the method further comprises a catheter hub-clipping step. The catheter hub-clipping step includes clipping together the proximal catheter-hub piece of the proximal catheter piece and the proximal catheter-hub piece of the distal catheter piece. The catheter hub-clipping step connects one or more extension-leg lumens of one or more extension legs coupled to a proximal catheter-hub piece to one or more catheter-tube lumens of a catheter tube, respectively, to form a RICC.

In some embodiments, the method further comprises a manipulation guidewire-advance step. The manipulation guidewire-advancing step includes advancing the manipulation guidewire into a vessel lumen through the primary lumen of the RICC having a primary lumen opening at the distal end of the distal catheter piece to a target location within the patient's vasculature.

In some embodiments, the method further comprises a second RICC-advance step and an operational guidewire-removal step. The second RICC-advance step includes advancing the remainder of the distal portion of the first section of the catheter tube to the proximal portion of the second section of the catheter tube into the vessel lumen using the manipulative guidewire as a guide. In the second RICC-advance step, advancement is stopped when the distal end of the distal catheter piece reaches the target position. The manipulation guidewire-removal step includes withdrawing the manipulation guidewire and leaving the catheter tube in place within the patient.

These and other features of the concepts presented herein will become more apparent to those skilled in the art from the accompanying drawings and the following description, which more specifically describe specific embodiments of the concepts.

1 shows a first perspective view of an introducer assembly comprising an introducer and a distal catheter piece of a two-piece RICC according to some embodiments.
2 shows a second perspective view of an introducer assembly in accordance with some embodiments.
3 shows a plan view of an introducer assembly in accordance with some embodiments.
4 shows a bottom view of an introducer assembly in accordance with some embodiments.
5 shows a side view of the introducer assembly in operation with the access guidewire advanced through the distal end of the distal catheter piece of the RICC in accordance with some embodiments.
6 shows a side view of the introducer assembly in another operational state with the distal catheter piece of the RICC and the split introducer housing advanced from a ready-to-deploy state of the introducer assembly, in accordance with some embodiments.
FIG. 7 shows a perspective view of the introducer assembly in the same operating condition as FIG. 6 , in accordance with some embodiments.
8 shows a sliding hinge in the proximal portion of the introducer housing according to some embodiments.
9 shows a lock in the distal portion of the introducer housing in accordance with some embodiments.
10 shows a syringe of an introducer according to some embodiments.
11 shows a longitudinal cross-sectional view of a portion of a syringe in accordance with some embodiments.
12 shows a catheter-advance hub coupled to a distal catheter-hub piece of a distal catheter piece in a ready-to-deploy state of an introducer assembly according to some embodiments.
13 illustrates a two-piece RICC in an unconnected state, in accordance with some embodiments.
14 shows a two-piece RICC in a connected state, in accordance with some embodiments.
15 shows a proximal catheter-hub piece and a distal catheter-hub piece of an unconnected two-piece catheter hub of a RICC, according to some embodiments.
16 shows a proximal catheter-hub piece and a distal catheter-hub piece in a coupled state of a RICC according to some embodiments.
17 shows a distal portion of the catheter tube of the RICC of FIGS. 13 and 14 in accordance with some embodiments.
18 shows a first cross-sectional view of the catheter tube of FIG. 17 in accordance with some embodiments.
19 shows a second cross-sectional view of the catheter tube of FIG. 17 in accordance with some embodiments.
20 shows a third cross-sectional view of the catheter tube of FIG. 17 in accordance with some embodiments.
21 shows a fourth or fifth cross-sectional view of the catheter tube of FIG. 17 in accordance with some embodiments.

This patent application claims the benefit of priority to US Provisional Patent Application Serial No. 63/059,798, filed on July 31, 2020, the aforementioned US Patent Application being incorporated herein by reference.

Before discussing some specific embodiments in detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It is also to be understood that a particular embodiment disclosed herein may have features that are readily separable from that particular embodiment, and that can be optionally combined with or substituted for features of any number of other embodiments disclosed herein. There will be.

With respect to the terms used herein, it should be understood that the terms are for the purpose of describing some specific embodiments and that the terms do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., 1st, 2nd, 3rd, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide serial or numerical limitations. no. For example, “first”, “second”, and “third” features or steps do not necessarily appear in that order, and a particular embodiment incorporating such features or steps necessarily includes all three features or steps. It need not be limited to steps. Labels such as “left”, “right”, “top”, “bottom”, “anterior”, “rear”, etc. are used for convenience and imply, e.g., any particular fixed location, orientation, or direction. It is not intended to Instead, such labels are used, for example, to reflect relative position, orientation, or orientation. Unless the context clearly dictates otherwise, the singular forms “a”, “an”, and “the” include plural referents.

With reference to "proximal", for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter that is intended to be proximate to a clinician when the catheter is used on a patient. Likewise, for example, the "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the "proximal end" of the catheter includes the end of the catheter that is intended to be proximate to the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of the catheter may include the proximal end of the catheter; The proximal portion, proximal end portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, proximal end portion, or proximal length of the catheter is not the distal portion or distal length of the catheter.

With reference to "distal", for example, the "distal portion" or "distal end portion" of a catheter disclosed herein refers to the portion of a catheter intended to be positioned proximate to or within a patient when the catheter is used with respect to a patient. includes Likewise, for example, the "distal length" of a catheter includes the length of the catheter intended to be positioned proximate to or within the patient, when the catheter is used with respect to the patient. For example, the “distal end” of a catheter includes the end of a catheter intended to be positioned proximate to or within a patient when the catheter is used on a patient. The distal portion, distal end portion, or distal length of the catheter may include the distal end of the catheter; The distal portion, distal end portion, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, distal end portion, or distal length of the catheter is not the distal portion or distal length of the catheter.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of skill in the art.

As noted above, the RICC generally includes a distal introduction aperture designed to introduce the RICC over a shorter introducer needle. However, it would be beneficial to eliminate the introduction apertures as they become artifacts in nature after RICC introduction.

To solve the above problems, a two-piece RICC, an introducer therefor, and a method method thereof are disclosed herein. For context, a description of RICC is provided first. The description of the RICC is followed by a description of the introducer, which is sometimes given in the context of the introducer assembly, taking into account the interrelationship of the introducer and the RICC. Following the description of the RICC and introducer, a method for at least using the RICC system including the aforementioned RICC and introducer is presented.

Rapidly insertable central catheter

13 and 14 show a two-piece RICC 100 in unconnected and connected states in accordance with some embodiments.

As shown, the two-piece RICC 100 includes two pieces, including a proximal catheter piece 102 and a distal catheter piece 104. It should be understood that the RICC 100 may include different or additional pieces than those in the illustrated embodiment. In practice, the “two-piece” of a two-piece RICC 100 is generally at least the result of splitting such a RICC laterally at some point along its length, in this case at the two-piece catheter hub 108 described below. refers to two pieces.

The proximal catheter piece 102 includes a proximal catheter-hub piece 106 of a two-piece catheter hub 108 and one or more extension legs 110 . The distal catheter piece 104 includes a distal catheter-hub piece 112 of a two-piece catheter hub 108 and a catheter tube 114 . A description of the two-piece catheter hub 108 is provided first, followed by a description of the catheter tube 114, one or more extension legs 110, and other aspects of the RICC 100.

15 and 16 show proximal catheter-hub piece 106 and distal catheter-hub piece 112 of two-piece catheter hub 108 in unconnected and connected states of RICC 100 according to some embodiments. shows

The proximal catheter-hub pieces 106 of the two-piece catheter hub 108 include one or more rigid tubes 116 (eg, metal tubes) each disposed in one or more proximal catheter-hub lumens 118. , effectively extending the one or more proximal catheter-hub lumens 118 within the connector. The proximal catheter-hub piece 106 may be molded over the one or more hard tubes 116 during manufacture such that the one or more hard tubes 116 extend from the distal end of the proximal catheter-hub piece 106 . Alternatively, one or more hard tubes 116 are inserted into one or more proximal catheter-hub lumens 118 during manufacture such that the one or more hard tubes 116 extend from the distal end of the proximal catheter-hub piece 106.

The distal catheter-hub piece 112 of the two-piece catheter hub 108 includes one or more distal catheter-hub lumens 120, each of which includes one or more mechanical gaskets 122 disposed therein. do. One or more mechanical gaskets 122 are provided between the abluminal surface of one or more rigid tubes 116 and the luminal surface of one or more distal catheter-hub lumens 120 in connection with the RICC 100. It is configured to be seated in The one or more mechanical gaskets 122 include, but are not limited to, 'O'-rings or cylinders. One or more mechanical gaskets 122 may be formed of a compressible polymeric material such as silicone. The use of a compressible polymeric material, such as silicone, provides axial compression of the one or more mechanical gaskets 122 by the compression ring 124 upon insertion of the one or more rigid tubes 116 into the one or more distal catheter-hub lumens 120. Allow one or more mechanical gaskets (122) to expand radially in the confined space between the lumenal outer surface of the one or more hard tubes (116) and the lumenal surface of the one or more distal catheter-hub lumens (120), thereby forming a two-piece catheter hub Create one or more fluid-tight luminal seals between the proximal catheter-hub piece (106) and the distal catheter-hub piece (112) of (108) and each one or more proximal catheter-hub lumens (118). It is advantageous in that it continues into one or more distal catheter-hub lumens 120 .

As an alternative to the foregoing, the distal catheter-hub piece 112 may instead include one or more rigid tubes 116 each disposed within one or more distal catheter-hub lumens 120 . Likewise, proximal catheter-hub pieces 106 may instead include one or more mechanical gaskets 122 each disposed within one or more proximal catheter-hub lumens 118 . The foregoing description of the one or more rigid tubes 116, one or more mechanical gaskets 122, etc., for the illustrated embodiments of the proximal catheter-hub piece 106 and distal catheter-hub piece 112 is the distal catheter-hub piece It should be understood that when part of 112 it applies to one or more hard tubes 116 and when part of proximal catheter-hub piece 106 it applies to one or more mechanical gaskets 122 .

Continuing the illustrated embodiment of the proximal catheter-hub piece 106 and distal catheter-hub piece 112, the proximal catheter-hub piece 106 and distal catheter-hub piece 112 include: RICC 100 and a complementary connector of a connection system configured to fixedly, and in some embodiments irreversibly, connect the proximal catheter-hub piece 106 and the distal catheter-hub piece 112 in a connected state. Connecting the proximal catheter-hub piece 106 and the distal catheter-hub piece 112 "irreversibly" in this context means that the proximal catheter-hub piece 106 and the distal catheter-hub piece 112 are tools or proximal. It should be understood to mean that it cannot be separated without damaging either the catheter-hub piece 106 or the distal catheter-hub piece 112.

Regarding the coupling system, the distal catheter-hub piece 112 may include an integral clip molded with the distal catheter-hub piece 112 itself, the integral clip extending proximally from the distal catheter-hub piece 112. It has a tabbed arm 126 that does. The proximal catheter-hub piece 106 has a complementary accommodation, such as a surface recess 128 configured to seat both the tab arm 126 and the tab 130 of the tab arm 126 in connection with the RICC 100. wealth may be included. As best seen in FIG. 15 , the tabbed arm 126 can extend from a major side of the distal catheter-hub piece 112 , and the surface recess 128 has a proximal catheter-hub piece 106 . ) can be on the main surface of Alternatively, however, the tapped arm 126 may extend from a minor side of the distal catheter-hub piece 112 and the surface recess 128 may extend from the minor surface of the proximal catheter-hub piece 106. can be in Due to the larger design space across the width of the two-piece catheter hub 108, instead of a complementary receptacle, the tabbed arm 126 extending from the minor side of the distal catheter-hub piece 112 is configured to be inserted. can be a longitudinal cavity inside the minor surface of the proximal catheter-hub piece 106, similar to a typical plastic buckle on a backpack or the like.

As an alternative to the foregoing, proximal catheter-hub piece 106 may instead include an integral clip with tabbed arm 126 . Indeed, if the one or more hard tubes 116 are also disposed within the one or more proximal catheter-hub lumens 118 of the proximal catheter-hub piece 106, the integral clip will protect the one or more hard tubes 116 from unintended damage. effectively protect Similarly, the distal catheter-hub piece 112 may instead include a complementary receptacle comprising a surface recess 128 configured to seat the tabbed arm 126 therein. The foregoing description of the tabbed arm 126, complementary receptacle, etc. for the illustrated embodiment of the proximal catheter-hub piece 106 and distal catheter-hub piece 112 may be part of the proximal catheter-hub piece 106. It should be understood that when applied to the tabbed arm 126 and when part of the distal catheter-hub piece 112 it is applied to the complementary receptacle.

17 shows a distal portion of catheter tube 114 of RICC 100 according to some embodiments. 18-21 show various cross-sections of catheter tube 114 according to some embodiments.

Catheter tube 114 is coupled to distal catheter-hub piece 112 by a proximal portion of catheter tube 114 . As such, each of the one or more distal catheter hub lumens 120 continues as one or more catheter-tube lumens. (For more than one catheter-tube lumen, see primary, secondary, and tertiary lumens 142, 146, and 150 of RICC 100 in FIG. 21 .)

Catheter tube 114 may include a hard portion and a soft portion, wherein “hard” and “soft” refer to the hard portion of catheter tube 114 being harder than the soft portion of catheter tube 114 in a relative sense. used The hard portion of the catheter tube 114 includes a first section 132 at the distal portion of the catheter tube 114, while the soft portion of the catheter tube 114 includes a first section 132 from the proximal portion of the catheter tube 114. and a second section 134 extending to the proximal, distal portion of section 132 . Despite the tapered junction 136 of the catheter tube 114 including the proximal portion of the hard portion of the catheter tube 114 disposed therein, the soft portion of the catheter tube 114 is generally of its construction. It is considered to include junction 136 in terms of. Together, the foregoing arrangement of the first section 132 of the catheter tube 114, the second section 134 of the catheter tube 114 and the abutment 136 provides an insertion site established by percutaneous puncture. Sufficient column strength to prevent buckling of the catheter tube 114 when inserted into the catheter tube 114 and a guidewire to manipulate the catheter tube 114 through the patient's vasculature to a target location (eg, superior vena cava ["SVC"]). Provide catheter tube 114 with sufficient conformability to advance upward.

The first section 132 of the catheter tube 114 is at the distal portion of the catheter tube 114 . The first section 132 extends beyond the remainder of the first section 132 from the needle tip 140 of the introducer needle 164 when the introducer needle 164 is placed within the catheter tube 114 of the distal catheter piece 104. and a distal tip 138 having a relatively short taper configured to continue to the outer diameter of the part. (See FIGS. 1-4 ) The short taper of the distal tip 138 provides immediate coverage of the tissue around the percutaneous puncture established with the introducer needle 164 up to the outer diameter of the remainder of the first section 132 of the catheter tube 114. configured for extension. The first section 132 also includes a proximal portion disposed in and rigidly coupled (e.g., solvent bonded, glued, welded, etc.) to the receptacle of an abutment 136 described below. do.

The first section 132 of the catheter tube 114 is formed of a first polymeric material having a first durometer. The first polymer material may be polytetrafluoroethylene, polypropylene or polyurethane, but the first polymer material is not limited to the aforementioned polymers. Polyurethane is advantageous in that the first section 132 of the catheter tube 114 can be relatively rigid at room temperature, but becomes more flexible in vivo at body temperature, reducing irritation to the vessel wall and phlebitis.

The second section 134 of the catheter tube 114 extends from the proximal portion of the catheter tube 114 to the proximal distal portion of the first section 132 of the catheter tube 114 . The second section 134 has a distal end coupled to an abutment 136, and is disposed on and rigidly coupled (eg, solvent bonded, welded, glued, etc.) to the distal catheter-hub piece 112. including the proximal portion of

The second section 134 of the catheter tube 114 is formed of a second polymeric material having a second durometer smaller than the first durometer. The second polymer material may be polyvinylchloride, polyethylene, polyurethane or silicone, but the second polymer material is not limited to the polymers described above. In addition to what was described above for the polyurethane in the first section 132 of the catheter tube 114, the polyurethane is advantageous in that it is less likely to cause blood clots than some other polymers.

Abutment 136 of catheter tube 114 couples first and second sections 132 , 134 of catheter tube 114 together. Abutment 136 is a receptacle to a distal portion including a proximal portion of first section 132 of catheter tube 114 disposed therein and fixedly coupled (eg, solvent bonded, welded, glued, etc.) includes (For the receptacle of abutment 136, see FIGS. 17 and 19 where the receptacle can be identified.) Abutment 136 is also at the flattened distal end of second section 134 of catheter tube 114. and a proximal end of a planar surface rigidly coupled (eg, molded, solvent bonded, welded, glued, etc. with second section 134), which, when coupled, comprises a primary A lumen of the second section 134 of the catheter tube 114 other than that corresponding to the lumen 142 effectively terminates passage through the abutment 136 . The abutment 136 also includes a taper spanning its length from the distal end to the proximal end, configured for immediate expansion of the tissue around the percutaneous puncture to the outer diameter of the second section 134 of the catheter tube 114 . The lumen outer surface of abutment 136 transitions smoothly from the lumen outer surface of the proximal portion of first section 132 without an edge catching the skin when inserted into a patient's insertion site. In addition to the minimal to negligible edge, the edge is the first polymeric material of the abutment 136 and the polymeric material that facilitates the transition from the first section 132 of the catheter tube 114 to the abutment 136. solvent-interdiffused polymeric materials.

The junction 136 of the catheter tube 114 is formed of a second polymeric material or a third polymeric material having a third durometer closer to the second durometer than the first durometer. Again, the second polymeric material may be polyvinylchloride, polyethylene, polyurethane or silicone, but the second polymeric material is not limited to the aforementioned polymers.

Again, first section 132 of catheter tube 114 is formed from a first polymeric material having a first durometer, and second section 134 of catheter tube 114 has a second durometer smaller than the first durometer. formed from a second polymeric material having a durometer, wherein the junction 136 of the catheter tube 114 is either the second polymeric material or a third polymeric material having a third durometer closer to the second durometer than the first durometer. is formed with Since the durometer of each of the second durometer and the third durometer is smaller than the first durometer, the second portion of the catheter tube 114 and the soft portion of the catheter tube 114 including the abutment 136 is the catheter tube Softer than the hard portion of the catheter tube 114 comprising the first portion of 114. In other words, the first durometer is larger than each of the second durometer and the third durometer. Since the first durometer is larger than each of the durometers of the second and third durometers, the hard portion of the catheter tube 114 comprising the first portion of the catheter tube 114 is It is more rigid than the soft part of the catheter tube 114 including the two parts and junction 136.

Since the first durometer of the first polymeric material, the second durometer of the second polymeric material, and the third durometer of the third polymeric material may be of different scales (e.g., type A or type D), It should be understood that the second durometer or the third durometer may not be numerically smaller than the first durometer. In other words, the first durometer material may not be numerically greater than the second durometer or the third durometer, taking into account the different scales. That is, the hardness of the second or third polymeric material may still be less than the hardness of the first polymeric material, or the hardness of the first polymeric material may still be greater than the hardness of the second or third polymeric material, respectively ranging from 0 to 0. This is because the different scales, which range from 100, are designed to characterize different materials of a group of materials with similar hardness.

Notwithstanding the foregoing, when the catheter tube 114 is inserted into the insertion site established by percutaneous puncture, the column strength of the catheter tube 114 is sufficient to prevent buckling of the catheter tube 114 and the catheter tube ( First section 132 of catheter tube 114, second section 134 of catheter tube 114, if compliance of 114) is sufficient to advance catheter tube 114 through the patient's vasculature to the target location. ) and junction 136 may be formed of the same polymeric material or may be formed of different polymeric materials having substantially the same durometer.

Each extension leg of the one or more extension legs 110 is coupled to the proximal catheter-hub piece 106 by a distal portion of the extension leg. The one or more extension legs 110 each include one or more extension-leg lumens. As such, each of the one or more proximal catheter-hub lumens 118 continues as one or more extended-leg lumens.

Each extension leg of the one or more extension legs 110 typically includes a Luer connector coupled to the extension leg through which the extension leg and its extension-leg lumen may be connected to other medical devices.

Whether the RICC 100 is a single lumen with one lumen or multiple lumens with a set of multiple lumens, the RICC 100 has at least a primary lumen 142 (e.g., distal lumens), wherein in connection the one or more catheter-tube lumens in the distal catheter piece (104) cross the two-piece catheter hub (108) to one or more extension-leg lumens in the proximal catheter piece (102). are fluidly connected to each other. The primary lumen 142 typically extends from the proximal end of the RICC 100 to the distal end of the RICC 100, for example from the opening of a corresponding Luer connector to the primary lumen opening at the distal end of the RICC 100 ( 144) (eg, distal-lumen opening). If the RICC 100 has two or more lumens, the RICC 100 further includes at least a secondary lumen 146 (eg, a medial lumen). The secondary lumen 146 typically extends from a proximal end of the RICC 100 to a distal portion of the RICC 100, e.g., a catheter tube (proximal to the primary lumen opening 144 from an opening of a corresponding Luer connector). 114) to the secondary lumen opening 148 (eg, medial-lumen opening). If the RICC 100 has three or more lumens, the RICC 100 further includes at least a tertiary lumen 150 (eg, a proximal opening). The tertiary lumen 150 typically extends from the proximal end of the RICC 100 to the distal portion of the RICC 100, eg, a catheter tube (proximal to the secondary lumen opening 148 from the opening of the corresponding Luer connector). 114) to the tertiary lumen opening 152 (eg, the proximal-lumen opening). Notwithstanding the foregoing, each lumen of secondary lumen 146 and tertiary lumen 150 is slightly larger than secondary lumen opening 148 and tertiary lumen opening 152, respectively, in terms of different fabrication methods. It can be extended distally. However, as described above, the flat-faced proximal end of the abutment 136 is rigidly coupled (e.g., the second section 134) to the flat-faced distal end of the catheter tube 114. Molded, solvent bonded, welded, glued, etc.) with section 134, which, when coupled, effectively terminates passage of lumens such as secondary and tertiary lumens 150 through junction 136.

Introducer and Introducer Assembly

1-4 show various views of an introducer assembly 154 that includes a distal catheter piece 104 and an introducer 156 of a two-piece RICC 100, according to some embodiments.

As shown, introducer 156 is configured to couple to distal catheter piece 104 of two-piece RICC 100 to form introducer assembly 154 . Indeed, FIGS. 1-4 show introducer 156 coupled with distal catheter piece 104 in a ready-to-deploy state of introducer assembly 154 (eg, ready for venipuncture). Introducer assembly 154 is held between the thumb and the other finger or fingers (eg, middle and ring fingers) of the hand while the introducer assembly 154 is held between at least three fingers (eg, index finger) of the same hand. configured to work in this way. Accordingly, multiple operational states of introducer assembly 154 are also possible, some of which are identified or identifiable in the description set forth below, including at least the description of methods for using a RICC system provided herein. .

Introducer 156 includes a syringe 162 that includes a catheter-advancing hub 158 , an introducer housing 160 , and an introducer needle 164 . A description of the catheter-advancing hub 158, introducer housing 160, and syringe 162 is presented in turn, followed by some other features of introducer 156. However, in view of the interrelationships of the foregoing features of introducer 156, there is some crossover between descriptions of other features of catheter-advance hub 158, introducer housing 160, syringe 162, and introducer 156. exists. Again, some of the description of introducer 156 is provided with respect to the introducer assembly given the interrelationship of introducer 156 and the RICC.

12 shows the catheter-advance hub 158 coupled to the distal catheter-hub piece 112 of the distal catheter piece 104 in a ready-to-deploy state of the introducer assembly 154, according to some embodiments.

As shown, the catheter-advancing hub 158 is configured to couple to the distal catheter piece 104 at the introducer assembly 154 . Indeed, FIG. 12 shows the catheter-advance hub 158 coupled with the proximal portion of the distal catheter-hub piece 112 in the ready-to-deploy state of the introducer assembly 154 .

Catheter-advance hub 158 includes manifold 166 , side arm 168 and catheter-advance push tab 170 extending proximally from side arm 168 . As best seen in FIG. 12 , catheter-advance hub 158 is an integral proximal connector configured to fluidly couple syringe 162 to catheter-advance hub 158 via a syringe tip (e.g., , female luer connector). This fluidic coupling between the catheter-advancing hub 158 and the syringe 162 allows observing blood flashback at the hub 204 of the syringe 162, if present, when establishing a needle track to the lumen of the patient's blood vessel. useful for

Manifold 166 includes the same number of one or more manifold lumens 172 as one or more distal catheter-hub lumens 120, each catheter-hub lumen having a distal catheter piece 104, as described above. as one or more catheter-tube lumens. In the ready-to-deploy state of the introducer assembly 154, the one or more manifold lumens 172 may be inserted into the one or more catheter-tube lumens prior to insertion of the distal catheter piece 104 or its catheter tube 114 into a lumen of a patient's blood vessel. It is fluidly connected via one or more distal catheter-hub lumens 120 to one or more catheter-tube lumens so that they can be simultaneously primed with fluid (eg, saline, heparinized saline, etc.).

As best seen in FIG. 12 , side arms 168 of catheter-advance hub 158 have side-arm lumens 174 fluidly coupled to one or more manifold lumens 172 and integral side arms 174 . -Includes an arm connector (eg female luer connector). The combination of the side-arm lumen 174 and the one or more manifold lumens 172 is therefore such that each lumen of the one or more catheter-tube lumens prior to insertion of the distal catheter piece 104 or catheter tube 114 into the lumen of a patient's blood vessel. configured for simultaneous priming of The needle shaft of the introducer needle 164 extends through the manifold 166, or at least one manifold lumen, and the distal end of the distal catheter piece 104 in the ready-to-deploy state of the introducer assembly 154. As such, simultaneous priming of each of the one or more catheter-tube lumens occurs around the introducer needle 164 in at least one manifold lumen when simultaneous priming is performed.

Catheter-advance push tab 170 maintains syringe 162 around its distal portion between the thumb and other finger or fingers of the hand (eg, middle and ring fingers) while catheter-advance push tab 170 ) is configured to push catheter-advance push tab 170 with one finger (eg, index finger) of the same hand to advance catheter-advance hub 158 distally, thereby causing catheter-advance push tab 170 configured to advance the distal catheter piece 104 through the distal catheter-hub piece 112 coupled thereto. Again, catheter-advancing push tab 170 extends proximally from side arm 168 of catheter-advancing hub 158 . Indeed, in the ready-to-deploy state of introducer assembly 154, catheter-advance push tab 170 extends proximally over a portion of plunger-withdrawal push tab 212 shown below, which in turn distal portion of syringe 162. Extend proximally upward. The aforementioned arrangement of the plunger-withdrawal push tab 212 and catheter-advance push tab 170 holds the syringe 162 around its distal portion between one finger and the thumb and the other finger or fingers of the same hand. while providing immediate access to the push tabs 170, 212 to operate the introducer assembly 154 with the one finger.

6 and 7 show different views of introducer assembly 154 in operation with introducer housing 160 divided along its length, in accordance with some embodiments.

As shown, the introducer housing 160 includes two pieces, including a slideable piece 176 and a stationary piece 178 configured to split open along the length of the introducer housing 160 . Indeed, in the ready-to-deploy state of introducer assembly 154 shown in FIGS. Although closed over the proximal portion of 104 , introducer housing 160 is split open in the operating state of introducer assembly 154 shown in FIGS. 6 and 7 . The introducer housing 160 retains the distal catheter piece 104 for venipuncture (e.g., the needle track-establishment step described below) with the introducer needle 164 while the introducer assembly 154 is ready for deployment. It is configured to provide column strength to the catheter tube 114. Additionally, at least a proximal portion of the catheter tube 114 is seated within the introducer housing 160 with the introducer assembly 154 ready for deployment, providing a no-touch mechanism that does not touch or contaminate the catheter tube 114 during venipuncture. .

9 shows locking portion 180 at the distal portion of introducer housing 160 in accordance with some embodiments.

As shown, the lock 180 includes a hook 182 on the slideable piece 176 of the introducer housing 160 and a latch 184 on the stationary piece 178 of the introducer housing 160. . Each of the hooks 182 and latches 184 may be integral (eg molded) with a respective piece of the intake housing. That is, the hook 182 may be integral with the slideable piece 176 and the latch 184 may be integral with the stationary piece 178 . The hook 182 and latch 184 are configured to lock the slidable piece 176 and stationary piece 178 together in a ready-to-deploy state of the introducer assembly 154 .

The stationary piece 178 of the introducer housing 160 also includes a channel 186 that can be molded into the stationary piece 178. Channel 186 then includes a latch 184 at a proximal portion of channel 186 and a ramp 188 at a distal portion of channel 186 . Like latch 184 , ramp 188 may be integral (eg molded) with stationary piece 178 . The combination of the ramp 188 and the hook 182 of the slideable piece 176 of the introducer housing 160 secures the slideable piece 176 while advancing the slideable piece 176 distally relative to the stationary piece 178. It is configured to push away from the fixation piece 178. Indeed, while advancing the slideable piece 176 distally relative to the stationary piece 178, the distal face of the hook 182 engages the proximal face of the ramp 188, which pulls the hook 182 out of the channel 186. Lift up and slide the slideable piece 176 away from the stationary piece 178 to split open the introducer housing 160 longitudinally.

8 shows a sliding hinge 190 at a proximal portion of introducer housing 160 according to some embodiments.

As shown, the sliding hinge 190 is coupled to a captive tab 192 of the slideable piece 176 of the introducer housing 160 and a track 194 within the stationary piece 178 of the introducer housing 160. ). Like the hook 182 , the captive tab 192 may be integral (eg, molded) with the slideable piece 176 . Like channel 186 , track 194 may be molded into stationary piece 178 . The captive tab 192 ensures that the slideable piece 176 rotates relative to the securing piece 178 without separating the slidable piece 176 from the securing piece 178 at the proximal portion of the introducer housing 160. It is positioned captive but slidably on the track 194 so that it can advance upward. That is, advancing the slideable piece 176 distally relative to the stationary piece 178 separates the slideable piece 176 from the stationary piece 178 at the distal portion of the introducer housing 160 as described above. In practice, the proximal portion of the captive tab 192 on the inside of the outer surface of the introducer housing 160 is undercut or radial, thereby distally distally relative to the fixation piece 178 the slideable piece 176. It facilitates the smooth separation of the slidable piece 176 from the stationary piece 178 at the distal portion of the introducer housing 160 while being advanced.

As further shown in FIG. 8 , the proximal portion of introducer housing 160 narrows as introducer-housing tabs 196 and introducer housing 160 tapers from the proximal portion of introducer housing 160 to the distal portion. The edge includes a longitudinal cut 198.

The introducer-housing tab 196 is the introducer housing 160 that the side arm 168 of the catheter-advance hub 158 can push while the catheter-advance hub 158 is advanced distally within the introducer housing 160. ) is configured to provide a point of Indeed, the aforementioned arrangement of the introducer-housing tab 196 and the side arm 168 of the catheter-advance hub 158 allows sliding of the introducer housing 160 by pushing the catheter-advance push tab 170 as described above. Allows piece 176 to be advanced distally relative to stationary piece 178 of introducer housing 160 .

Longitudinal cut 198 is configured to provide a narrowing path that side arm 168 of catheter-advance hub 158 follows while advancing catheter-advance hub 158 distally, which narrowing path is configured for side arm based separation of the slidable piece 176 from the stationary piece 178 while advancing the side arm 168 of the catheter-advancing hub 158 distally through the narrowing path. For example, while advancing the slideable piece 176 distally relative to the stationary piece 178 by the catheter-advancing hub 158, the hook 182 of the slideable piece 176 may engage the ramp of the stationary piece 178. When lifted out of channel 186 by 188, introducer-housing tab 196 pivots over side arm 168 so that side arm 168 is in the narrowing path provided by longitudinal cutout 198. allow you to enter Because the longitudinal cutout 198 narrows from the proximal portion to the distal portion of the introducer housing 160, the side arm 168 of the catheter-advance hub 158 is such that the side arm 168 has a longitudinal cutout ( 198), the slideable piece 176 continues to be raised and separated from the stationary piece 178. When the introducer housing 160 is sufficiently split open and the distal catheter piece 104 of the RICC 100 is advanced distally from its initial position in the ready-to-deploy state of the introducer assembly 154, the distal catheter-hub piece 112: It can be used to manually decouple the distal catheter-hub piece 112 from the manifold 166 of the catheter-advancing hub 158 and remove the distal catheter piece 104 from the introducer housing 160.

In particular, introducer housing 160 has slideable piece 176 and stationary piece 178 locked together by locking portion 180 until after venipuncture when catheter-advancing hub 158 is advanced as described above. It is configured to remain as it is.

10 shows syringe 162 of introducer 156 according to some embodiments.

The syringe 162 includes a plunger 200 disposed within a barrel 202 having a distal portion terminating in a syringe tip to which an introducer needle 164 is fluidly coupled and fixedly attached. As best seen in FIG. 12 , the syringe tip includes a syringe-tip connector (e.g., a male Luer connector), which, in readiness for deployment of introducer assembly 154, via at least its proximal coupler, catheter-tip connector It is configured to be fluidly coupled to the advancement hub 158 . Optionally, the syringe tip may include a side arm 206 coupled to a hub 204 and a fluid-pressure indicator 228 described below. The syringe 162 also includes a syringe housing 208 around the barrel 202 . As described below, the syringe housing 208 holds one finger (eg, index finger) of the hand to actuate the introducer assembly 154 while holding the thumb and another finger or fingers (eg, index finger) of the same hand. , middle or ring fingers) to hold the syringe 162 around the distal portion of the barrel 202 . Maintaining and handling the introducer assembly 154 as described above allows better control of the introducer assembly 154 and distal catheter piece 104, particularly during venipuncture.

The syringe housing 208 extends from the distal end of the distal portion of the syringe housing 208 around the distal portion of the barrel 202 of the syringe 162, the syringe housing 208 approximately coextensive with the proximal end of the barrel 202. extends to the proximal end of the proximal portion of the The syringe housing 208 has a gripping portion 210 (eg, a pattern of bumps, through-holes, etc.) configured to facilitate gripping the syringe 162 and thus the introducer 156 or introducer assembly 154 at the distal portion. ), as noted above, a portion of which is around the distal portion of the barrel 202 between the thumb and another finger or fingers of the same hand. The distal placement of the gripping portion 210 around the distal portion of the barrel 202 is at the distal portion of the introducer assembly 154, eg, the first section 132 of the catheter tube 114 of the distal catheter piece 104. Facilitates handling and holding the introducer assembly 154 in a position that provides better control over the Indeed, by holding and handling the introducer assembly 154 in the position described above, a small unintended yaw or pitch_type of motion is the same type of motion when the introducer assembly 154 is held in a more proximal position. Relatively little remains in the first section 132 of the catheter tube 114 compared to the movement of the catheter tube 114 .

The syringe housing 208 and plunger 200 are configured to operate together as a single unit as long as the syringe 162 is actuated (eg, the plunger 200 is withdrawn for a blood-suction step described below). do. The syringe housing 208 and the plunger 200 or its end piece 220 may be molded together as an integral piece such that the proximal portion of the syringe housing 208 is integral with the proximal portion of the plunger 200. Alternatively, the syringe housing 208 and the plunger 200 or its end piece 220 can be molded separately and then the proximal portion of the syringe housing 208 is molded to the plunger 200 or its end piece 220. may be coupled together in the form of a coupled piece so as to be coupled to a proximal portion of the . For example, the inner wall of the proximal end of the syringe housing 208 may be bonded or welded to the plunger flange of the distal end of the plunger 200 or its end piece 220 . Whether the syringe housing 208 and the plunger 200 are integral with each other or coupled, sliding the syringe housing 208 proximally relative to the barrel 202 withdraws the plunger 200 from the barrel 202, causing the syringe 162 is operated as a single unit.

Syringe 162 may further include a plunger-withdrawal push tab 212, which is a distal portion of barrel 202 to which plunger-withdrawal push tab 212 is coupled, for example by a ring-type coupler. (eg, a syringe tip) proximally up the barrel 202 . (See FIG. 12 ) The plunger-withdrawal push tab 212 is configured for use when actuating the syringe 162 as described above. In practice, the plunger-withdrawal push tab 212 holds the syringe housing 208 around the distal portion of the barrel 202 between the thumb and the other finger or fingers (eg, middle and ring fingers) of the same hand while holding the syringe housing 208. is configured to push with one's finger (eg, index finger), which slides the syringe housing 208 proximally relative to the barrel 202 and withdraws the plunger 200 from the barrel 202 .

11 shows a longitudinal cross-sectional view of a portion of syringe 162 according to some embodiments.

As shown, the syringe 162 also includes a syringe portion of the access-guidewire lumen 214 formed by the fluidic connection portion of the plunger lumen of the plunger 200, the syringe-tip lumen of the syringe tip, and introducer assembly 154. any space within the barrel 202 formed by partially pulling the plunger 200 out of the barrel 202, such as in the operating state of (e.g., during the blood suction step of the method described below). Another portion of access-guidewire lumen 214 is the introducer-needle portion of access-guidewire lumen 214, i.e., the needle lumen of introducer needle 164.

The plunger 200 includes a sealing mechanism 216 at a distal portion of the plunger 200 to seal an access-guidewire lumen 214 distal to the sealing mechanism 216 . Sealing mechanism 216 is configured to seal access-guidewire lumen 214 to maintain a vacuum for drawing blood when plunger 200 is withdrawn from barrel 202 . Sealing mechanism 216 may also be used to pass blood through the longitudinal slots of barrel 202 and plunger 200 described below during venipuncture or during withdrawal of access guidewire 222 described below from the lumen of a patient's blood vessel. configured to seal the access guidewire lumen 214 to prevent it from draining (eg, backflow), thereby minimizing or preventing the possibility of contaminating the surgical area or any clinician within the surgical area.

11 , the sealing mechanism 216 may be a cartridge disposed in the cavity of the distal portion of the body 218 of the plunger 200 and retained within the cavity by the end piece 220 of the plunger 200. can The cartridge has an unwrapped bare-wire portion of the access guidewire 222 through-holes at the proximal and distal ends of the cartridge having an inner diameter corresponding to the outer diameter of the bare-wire portion of the access guidewire 222. To pass through, it is coaxially aligned with the access guidewire lumen 214 or the plunger-lumen portion thereof. Optionally, the sealing mechanism 216 includes one or more gaskets, such as 'O'-rings, within or as an alternative to the cartridge. For example, instead of a cartridge, one or more 'O'-rings may be axially compressed within the cavity by the end piece 220 of the plunger 200, which in turn creates an 'O' around the access guidewire 222. Compress the '-ring radially to seal the access guidewire lumen 214.

5 shows a side view of the introducer assembly 154 in another operative state with the access guidewire 222 advanced through the distal end of the distal catheter piece 104, in accordance with some embodiments.

Access guidewire 222 ensures that at least a portion of access guidewire 222 is always a portion of access-guidewire lumen 214 (e.g., a plunger-lumen portion, a needle, regardless of the state of introducer assembly 154). - lumen portion, etc.), it is placed captive in the introducer 156. For example, when access guidewire 222 is withdrawn to its proximal limit (eg, defined by the proximal end of the longitudinal slot described below), the proximal portion of access guidewire 222 is drawn into the plunger lumen. disposed at least in the proximal portion of the Meanwhile, the distal portion of the access guidewire 222 is disposed in the distal portion of the needle lumen. When introducer assembly 154 is at least in its ready-to-deploy state, the proximal portion of access guidewire 222 is disposed in the medial portion of the plunger lumen and the distal portion of access guidewire 222 is disposed in the medial portion of the needle lumen. It remains deployed in the distal portion. However, the distal end of access guidewire 222 is advanced in the needle lumen such that the distal end of access guidewire 222 is slightly short of needle tip 140 . and when the access guidewire 222 is in some of the many operating states of the introducer assembly 154 (e.g., during the access guidewire-advance phase of the method described below), (e.g., the species described below). When advanced to its distal limit (determined by the distal end of the directional slot), the proximal portion of the access guidewire 222 is placed in the distal portion of the plunger lumen. On the other hand, as a result of its length, the distal end of the access guidewire 222 extends through or beyond the distal end of the distal catheter piece 104, which is necessary for establishing access after the needle track-establishment step described below. This is sufficient to extend the access guidewire 222 into the patient's vessel lumen.

The syringe 162 also includes a slider 224 (eg, a tab-like slider) that extends distally from under the syringe housing 208 and over the barrel 202 . Slider 224 is moved (e.g., with one finger (e.g., index finger) of the same hand) while holding the distal portion of syringe housing 208 between the thumb and the other finger or fingers (e.g., middle and ring fingers) of the hand. eg, with a scroll wheel type movement of a finger, such as used on a computer mouse) to actuate the access guidewire 222 . Slider 224 extends through longitudinal slots (not shown) in barrel 202 and plunger 200, respectively, into proximal access-guidewire lumen 214 of sealing mechanism 216 with extension 226. , wherein an extension 226 in the lumen is coupled to an access guidewire 222 . The proximal and distal ends of the longitudinal slots provide stops for the extension 226 and thus provide a limited tract for the extension 226 to move proximally or distally, thus providing access guidewire 222. It provides proximal and distal limits for withdrawing or advancing the introductor 156 into or out of the introducer 156, respectively.

10 shows the syringe 162 of the introducer 156 including a fluid-pressure indicator 228 in accordance with some embodiments.

As shown, a fluid-pressure indicator 228 extends from the side arm 206 of the hub 204 when present. The fluid-pressure indicator 228 includes a closed end and an open end fluidly coupled to the needle lumen of the introducer needle 164 via the side-arm lumen of the side arm. The fluid-pressure indicator 228 is configured as a built-in accidental arterial indicator, wherein blood under sufficient pressure (eg arterial blood) enters the fluid-pressure indicator 228 and fluid-pressure A column of air within the indicator 228 may be compressed. However, in some cases, it is also possible to observe the blood flashback from the venipuncture in the fluid-pressure indicator 228. That is, blood flashback from a venipuncture is usually observed at hub 204 , side arm of hub 204 or syringe 162 .

method

Methods for RICC systems provided herein include methods using at least a RICC system. A method of using such a RICC system may include a RICC system-acquisition step, a needle track-establishment step, a first RICC advancing step, an introducer housing-splitting step, and an introducer-removing step.

The RICC system-acquisition phase includes RICC system acquisition. As noted above, the RICC system includes a proximal catheter piece 102 of a RICC 100 and an introducer assembly 154. Introducer assembly 154 again includes distal catheter piece 104 of RICC 100 disposed partially within introducer housing 160 of introducer 156 .

The method may further include a needle tip-secured step before the needle track-established step. Again, introducer needle 164 has a needle shaft that extends through the distal end of distal catheter piece 104 in the ready-to-deploy state of introducer assembly 154 . The needle tip-establishing step includes ensuring that the needle tip 140 extends from the distal end of the distal catheter piece 104 prior to the needle track-establishing step.

The method may further include a priming step prior to the needle track-establishing step. The priming step includes priming the distal catheter piece 104 with a common syringe through the side arm 168 of the catheter-advance hub 158 prior to the first RICC-advance step. As noted above, side-arm 168 is a side-arm lumen fluidly coupled to one or more manifold lumens 172 for simultaneously priming each lumen of each one or more lumens of distal catheter piece 104. (174).

The needle track-establishing step includes establishing a needle track from the patient's skin region to the vessel lumen with the introducer needle 164 of the introducer. The needle track-establishment step is performed while holding the distal portion of the syringe 162 of the introducer 156 between the thumb of one hand and the other finger or fingers (eg, ring and middle fingers). Meanwhile, at least one finger (eg, index finger) of the same hand remains readily available to actuate introducer assembly 154 .

The needle track-establishment step ensures that blood flows back into the hub 204, the side arm of the hub 204, or the fluid-pressure indicator 228 extending from the side arm of the hub 204 when establishing the needle track. may further include

The method further includes a blood aspiration step. The blood aspiration step includes aspirating blood into the syringe 162 to ensure that the needle tip 140 of the introducer needle 164 is placed within the vessel lumen prior to the introducer-removal step. The blood aspiration step involves the plunger with one finger of the same hand while holding the distal portion of the syringe 162 by the syringe housing 208 over the barrel 202 of the syringe 162 between the thumb and the other finger or fingers of the hand. -Pushing the pull out push tab 212. The plunger-withdrawal push tab 212 slides the syringe housing 208 proximally relative to the barrel 202 when the plunger-withdrawal tab is pushed while retaining the distal portion of the syringe 162 by the syringe housing 208 . Extends from the distal portion of the syringe 162 over the barrel 202 to withdraw the plunger 200 connected to the barrel 202 .

The method may further include an access guidewire-advance step. The access guidewire-advancing step includes advancing the access guidewire 222 disposed within the access guidewire lumen 214 over the distal end of the distal catheter piece 104 and into the vessel lumen. As noted above, access-guidewire lumen 214 is formed by at least the plunger lumen of syringe 162 and the needle lumen of introducer needle 164, the distal end of access guidewire 222 being needle tip 140. is within the needle lumen, facilitating first-stick success by allowing the access guidewire 222 to be used immediately before the blood lumen vessel can be lost due to a small inadvertent movement. do. In addition, the slider 224 can be moved away from the access guidewire by advancing the slider 224 distally with one finger of the same hand while holding the distal portion of the syringe housing 208 between the thumb and the other finger or fingers of the hand. 222) is coupled to the access guidewire 222 for advancement into the vessel lumen. The access guidewire-advance step is performed before the first RICC-advance step.

The first RICC-advance step includes advancing the distal portion of the first section 132 of the catheter tube 114 of the distal catheter piece 104 over the needle shaft and into the lumen of the vessel. As described above, the catheter tube 114 has a first section 132 formed of a first material having a first durometer and a second section formed of a second material having a second durometer less than the first durometer ( 134). The first section 132 of the catheter tube 114 is used for advancing the catheter tube 114 into the access guidewire 222 or into the lumen of the vessel over the manipulation guidewire after the manipulative guidewire-advance step described below. It is configured with column strength.

The first RICC advance-step is to push the catheter-advance pressure tab 170 with one finger of the same hand while holding the distal portion of the syringe 162 between the thumb and the other finger or fingers of the hand to remove the catheter tube 114. advancing the distal portion of the first section 132 of the needle shaft and into the lumen of the blood vessel. Again, the catheter-advance push tab 170 is part of the catheter-advance hub 158 coupled to the proximal portion of the distal catheter piece 104 in the ready-to-deploy state of the introducer assembly 154 .

The introducer housing-splitting step includes unlocking the locking portion 180 on the distal portion of the introducer housing 160 and then splitting the introducer housing 160 along its length. Unlocking the locking portion 180 engages the hook 182 of the slidable piece 176 of the introducer housing 160 by sliding the slideable piece 176 distally relative to the stationary piece 178 and the introducer housing ( and removing the latch 184 of the fixing piece 178 of 160. The locking portion 180 can be manually unlocked by sliding the slideable piece 176 against the securing piece 178, while the introducer assembly 154 is provided by the catheter-advance push tab of the catheter-advance hub 158. Pushing 170 against introducer-housing tab 196 configures slidable piece 176 to slide against stationary piece 178 . Releasing the lock 180 according to the latter while holding the introducer assembly 154 around the distal portion of the syringe 162 will prevent the introducer assembly 154 from being stumbled or dropped, or distal catheter piece from the introducer assembly 154. Minimizes problems associated with excessive handling of the introducer assembly 154, such as contaminating any exposed portion of the catheter tube 114 of 104.

With respect to dividing the introducer housing 160, the fixing piece 178 of the introducer housing 160 is positioned at the distal portion of the channel 186 and the latch 184 at the proximal portion of the channel 186 as described above. and a channel 186 including a ramp 188 therein. Sliding the slideable piece 176 distally against the stationary piece 178 engages the distal face of the hook 182 with the proximal face of the ramp 188 and lifts the hook 182 out of the channel 186. Accordingly, the introducer housing 160 is divided along its length. The introducer housing 160 can be manually split by sliding the slideable piece 176 relative to the stationary piece 178, while the introducer assembly 154 has a catheter-advance push tab of the catheter-advance hub 158. Pushing on 170 is configured to advance side arm 168 of catheter-advancing hub 158 along a path provided by longitudinal cutout 198 in introducer housing 160 . Because the longitudinal cutout 198 narrows from the proximal portion to the distal portion of the introducer housing 160, the side arm 168 of the catheter-advance hub 158 is such that the side arm 168 has a longitudinal cutout ( 198), the slideable piece 176 continues to be raised and separated from the stationary piece 178.

The introducer-removing step removes the distal catheter piece 104 from the introducer housing 160, withdraws the introducer 156 from the distal catheter piece 104, and removes the distal first section 132 of the catheter tube 114. leaving the portion in place within the lumen of the blood vessel. Retracting the introducer 156 from the distal catheter piece 104 includes retracting both the needle shaft and access guidewire 222 from the distal catheter piece 104 .

The method further includes a catheter hub-clipping step. The catheter hub-clipping step includes clipping the proximal catheter-hub piece 106 of the proximal catheter piece 102 and the proximal catheter-hub piece 106 of the distal catheter piece 104 together. The catheter hub clipping step connects the one or more extension leg lumens of the one or more extension legs 110 coupled to the proximal catheter-hub piece 106 to the one or more catheter-tube lumens of the catheter tube 114, respectively, to achieve a 2- A piece forms the RICC 100 and its lumen over the catheter hub 108.

The method may further include a manipulation guidewire-advance step. The manipulative guidewire-advance step is via the primary lumen 142 of the RICC 100 having the primary lumen opening 144 at the distal end of the RICC 100 to a target location within the patient's vasculature (e.g., SVC). ) to advance the manipulation guidewire into the vessel lumen.

The method may further include a second RICC-advance step and an operating guidewire-removal step. The second RICC-advance step uses the manipulation guidewire as a guide to guide the remainder of the distal portion of the first section 132 of the catheter tube 114 to the proximal portion of the second section 134 of the catheter tube 114. advancing deeper into the vessel lumen. The manipulation guidewire provides column strength to the second section 134 of the catheter tube 114 for the second RICC-advance step. The second RICC-advance phase is stopped when the distal end of the distal catheter piece 104 reaches the target position (eg, SVC). The manipulation guidewire-removal step includes withdrawing the manipulation guidewire and leaving the catheter tube 114 in place within the patient.

Although some specific embodiments have been disclosed herein and certain embodiments have been disclosed in some detail, such specific embodiments are not intended to limit the scope of the concepts presented herein. Additional adaptations and/or modifications may be made by those skilled in the art and, in a broader sense, such adaptations and/or modifications are also included. Accordingly, adaptations and/or modifications may be made from the specific embodiments disclosed herein without departing from the scope of the concepts presented herein.

Claims (29)

As a rapidly insertable central catheter (RICC) system,
distal catheter-hub piece of a two-piece catheter hub; and
a catheter tube comprising at least one catheter-tube lumen, the catheter tube being coupled to the distal catheter-hub piece by a proximal portion of the catheter tube;
A distal catheter piece of the RICC comprising a; and
introductory period;
including,
The introducer assembly having a ready-to-deploy state, wherein the introducer is configured to be operated with a single finger of the hand while the introducer is held between the thumb and the other finger or fingers of the hand. Is configured to engage with the distal catheter piece in,
The introduction period,
a catheter-advancement hub comprising a manifold and side arms and coupled to a proximal portion of the distal catheter-hub piece in a ready-to-deploy state of the introducer assembly;
an introducer needle having a needle shaft extending through the manifold and the distal end of the distal catheter piece in the ready-to-deploy state of the introducer assembly;
a syringe comprising a barrel having a distal portion terminating in a syringe tip and fluidly coupled to the introducer needle; and
an introducer housing spanning the syringe tip, the manifold, and a proximal portion of the distal catheter piece when the introducer assembly is ready for deployment;
including,
The introducer housing,
providing column strength to the catheter tube during venipuncture of the patient with the introducer needle; and
longitudinally segmented to allow removal of the distal catheter piece from the introducer housing after the venipuncture.
RICC system. According to claim 1,
The introducer housing,
a lock at a distal portion of the introducer housing comprising a hook on a slidable piece of the introducer housing and a latch on a stationary piece of the introducer housing - the hook and the latch are configured to lock the slidable piece and the stationary piece together in a ready-to-deploy state of the introducer assembly;
including,
RICC system. According to claim 2,
The stationary piece of the introducer housing comprises a channel, the channel comprising the latch at a proximal portion of the channel and a ramp at a distal portion of the channel, the combination of the hook and the ramp comprising: configured to push the slidable piece of the introducer housing away from the fixation piece when the distal face of the hook engages the proximal face of the ramp while advancing the slidable piece distally relative to the fixation piece.
RICC system. According to claim 2 or 3,
a sliding hinge at a proximal portion of the introducer housing, the introducer housing comprising a captive tab of the slideable piece of the introducer housing and a track of the stationary piece of the introducer housing; ),
The captive tab is captive within the track so that the slideable piece can be advanced distally relative to the stationary piece without separating the slideable piece from the stationary piece at the proximal portion of the introducer housing. (captively) but slideably positioned,
RICC system. According to claim 4,
The proximal portion of the captive tab on the inside of the outer surface of the introducer housing is radial to facilitate separating the slidable piece of the introducer housing from the stationary piece of the introducer housing at the distal portion of the introducer housing. which is radiused,
RICC system. According to claim 5,
wherein the proximal portion of the introducer housing comprises a longitudinal cutout configured to provide a pathway for the side arm of the catheter-advancing hub while advancing the catheter-advancing hub distally within the introducer housing.
RICC system. According to any one of claims 1 to 3,
The manifold includes one or more manifold lumens equal in number to the one or more catheter-tube lumens, the one or more manifold lumens being fluidly coupled to the one or more catheter-tube lumens in a ready to deploy position of the introducer assembly. connected,
RICC system. According to claim 7,
The side arm of the catheter-advancing hub may fluidly flow into the one or more manifold lumens for simultaneously priming each of the one or more catheter-tube lumens prior to insertion of the catheter tube into the lumen of a patient's blood vessel. Comprising a coupled side-arm lumen,
RICC system. According to any one of claims 1 to 3,
The catheter-advance hub is configured to advance the catheter-advance hub distally with the single finger of the hand while gripping the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand. and further comprising a catheter-advancement push tab extending from the side arm.
RICC system. According to any one of claims 1 to 3,
The RICC further comprises a proximal catheter piece;
The proximal catheter piece,
a proximal catheter-hub piece of the two-piece catheter hub, and
one or more extension-legs each containing one or more extension-leg lumens;
including,
each extension leg of the one or more extension legs is coupled to the proximal catheter-hub piece by a distal portion of the extension leg;
The RICC is configured such that the proximal catheter-hub piece is fluidly coupled to the distal catheter-hub piece such that the one or more extended-leg lumens are fluidly coupled to the one or more catheter-tube lumens, respectively, across the two-piece catheter hub. Having a connected state that is connected,
RICC system. According to claim 10,
The RICC includes a set of three lumens in the connected state of the RICC, the set of three lumens including a primary lumen, a secondary lumen, and a tertiary lumen,
RICC system. According to claim 11,
the primary lumen having a primary lumen aperture at the distal end of the two-piece catheter and the secondary lumen having a secondary lumen aperture on a side of the catheter tube proximal to the primary lumen aperture; and wherein the tertiary lumen has a tertiary lumen opening on a side of the catheter tube proximal to the secondary lumen opening.
RICC system. According to any one of claims 1 to 3,
The catheter tube,
a first section formed of a first material having a first durometer; and
A second section formed of a second material having a second durometer smaller than the first durometer
By further including
wherein the catheter tube is configured to have both column strength for insertion of the catheter tube into a patient and compliance for advancing the catheter tube through the patient's vasculature.
RICC system. According to any one of claims 1 to 3,
The introducer further comprises a syringe housing around the barrel of the syringe, having a distal portion and a proximal portion, the proximal portion of the syringe housing sliding the syringe housing proximally relative to the barrel. integral with or coupled to a proximal portion of the plunger disposed in the barrel to withdraw the plunger from the barrel;
RICC system. According to claim 14,
the syringe further comprises a plunger-withdrawal push tab;
the plunger-withdrawal push tab extends proximally up the barrel from a distal portion of the barrel to which the plunger-withdrawal push tab is coupled; and
The plunger-withdrawal push tab pushes the syringe housing proximally against the barrel by pushing with the single finger of the hand while holding the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand. configured to slide and withdraw the plunger from the barrel,
RICC system. According to claim 14,
the introducer further comprises an access guidewire disposed in an access-guidewire lumen formed by at least a plunger lumen of the plunger and a needle lumen of the introducer needle;
Wherein the access guidewire is of sufficient length to extend the access guidewire through the distal end of the distal catheter piece.
RICC system. According to claim 16,
The introduction period,
Extending distally from the syringe housing over the barrel and actuating the access guidewire with the single finger of the hand while holding the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand. Further comprising a slider configured to
The slider includes an extension extending into the access-guidewire lumen through a longitudinal slot of each of the barrel and the plunger, the extension being coupled to the access guidewire,
RICC system. An introducer for a rapid insertable central catheter ("RICC") comprising:
a catheter-advancement hub comprising a manifold and side arms and configured to couple to a distal catheter piece of the RICC at an introducer assembly;
an introducer needle having a needle shaft configured to extend through the manifold and the distal end of the distal catheter piece in a ready-to-deploy state of the introducer assembly;
a barrel fluidly coupled to the introducer needle and having a distal portion terminating in a syringe tip, and between the thumb and the other finger or fingers of the hand, leaving a single finger to actuate the introducer. a syringe configured to be gripped around a distal portion of the barrel; and
an introducer housing spanning the syringe tip, the manifold, and a proximal portion of the distal catheter piece when the introducer assembly is ready for deployment;
including,
The introducer housing,
providing column strength to the catheter tube of the distal catheter piece during venipuncture of a patient with the introducer needle; and
longitudinally segmented to allow removal of the distal catheter piece from the introducer housing after the venipuncture.
introductory period. According to claim 18,
The introducer housing,
a lock at a distal portion of the introducer housing, comprising a hook on a slidable piece of the introducer housing and a latch on a stationary piece of the introducer housing; - the hook and latch are configured to lock the slideable piece and the stationary piece together;
including,
introductory period. According to claim 19,
The stationary piece of the introducer housing comprises a channel, the channel comprising the latch at a proximal portion of the channel and a ramp at a distal portion of the channel, wherein the hook and ramp combination is the slidable configured to push the slidable piece of the introducer housing away from the fixation piece when the distal face of the hook engages the proximal face of the ramp while advancing the piece distally relative to the fixation piece.
introductory period. The method of claim 19 or 20,
a sliding hinge at a proximal portion of the introducer housing, wherein the introducer housing includes a captive tab of the slideable piece of the introducer housing and a track of a stationary piece of the introducer housing. Including,
The captive tab is captive within the track so that the slideable piece can be advanced distally relative to the stationary piece without separating the slideable piece from the stationary piece at the proximal portion of the introducer housing. (captively) but slideably positioned,
introductory period. According to claim 21,
The proximal portion of the captive tab on the inside of the outer surface of the introducer housing is radial to facilitate separating the slidable piece of the introducer housing from the stationary piece of the introducer housing at the distal portion of the introducer housing. which is radiused,
introductory period. The method of claim 22,
wherein the proximal portion of the introducer housing comprises a longitudinal cutout configured to provide a pathway for a side arm of the catheter-advancing hub while advancing the catheter-advancing hub distally within the introducer housing.
introductory period. The method of any one of claims 18 to 20,
a side arm of the catheter-advance hub fluidly couples to the one or more manifold lumens for simultaneously priming each lumen of the one or more distal catheter piece lumens of the RICC in a ready-to-deploy state of the introducer assembly; comprising a ringed side-arm lumen,
introductory period. The method of any one of claims 18 to 20,
The catheter-advance hub is configured to advance the catheter-advance hub distally with the single finger of the hand while gripping the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand. and further comprising a catheter-advancement push tab extending from the side arm.
introductory period. The method of any one of claims 18 to 20,
The introducer further comprises a syringe housing around the barrel of the syringe, having a distal portion and a proximal portion, the proximal portion of the syringe housing proximally sliding the syringe housing relative to the barrel to cause the integral with or coupled to a proximal portion of a plunger disposed in the barrel to withdraw the plunger from the barrel;
introductory period. The method of claim 26,
the syringe further comprises a plunger-withdrawal push tab, the plunger-withdrawal push tab extending proximally up the barrel from a distal portion of the barrel to which the plunger-withdrawal push tab is coupled; , and
The plunger-withdrawal push tab slides the syringe housing proximally against the barrel by pushing with a single finger of the hand while grasping the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand. And configured to withdraw the plunger from the barrel,
introductory period. The method of claim 27,
the introducer further comprises an access guidewire disposed in an access-guidewire lumen formed by at least a plunger lumen of the plunger and a needle lumen of the introducer needle;
wherein the access guidewire has a length sufficient to extend the access guidewire through the distal end of the distal catheter piece in a ready-to-deploy condition of the introducer assembly.
introductory period. According to claim 28,
The introduction period,
Extending distally from the syringe housing up the barrel and actuating the access guidewire with a single finger of the hand while gripping the syringe around the distal portion of the barrel between the thumb and the other finger or fingers of the hand. Further comprising a slider configured to
The slider includes an extension extending into the access-guidewire lumen through a longitudinal slot of each of the barrel and the plunger, the extension being coupled to the access guidewire,
introductory period.

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